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Treatment To Prevent Fractures in Men and Women With Low Bone Density or Osteoporosis: An Update

Slide: 16 of 40

Summary of Study Characteristics Evaluated in the Effectiveness Review: PICOTS

Development of clinical studies of effectiveness of medical interventions is guided by the PICOTS (population, interventions, comparators, outcomes, timing, and setting) framework. These items are critical elements that will help to answer important clinical questions. In the CER, the clinical study literature was reviewed and summarized by using the PICOTS framework. The evidence concerning the outcomes identified here was examined in:

P
opulation:
Adults over 18 including healthy adults, those with LBD, those with osteoporosis, and adults at risk of LBD and osteoporosis due to chronic use of glucocorticoids or as a result of a condition associated with LBD (e.g. rheumatoid arthritis, cystic fibrosis, Parkinson’s disease).

Interventions: Pharmacological interventions for prevention or treatment of osteoporosis approved or soon to be approved by the FDA, calcium, vitamin D, or physical activity.

Comparators: Placebo, other doses, other agents in the same or another class

Outcomes: Vertebral, hip, and total fractures, fractures reported as outcomes, not as adverse events

Timing: Minimum of 6 months

Setting: All settings